DNA Microarrays: FDA's Consortium Looks to Establish Best Practices for Genetic Data in Regulatory Review Process
Wilfredo Ortiz
- Published Content: 4
- Total Views: 1,999
- Favorited By: 0 CPs
Biomedical applications has opened new roads in the nanotechnology highway. The merge between biomedicine and nanotechnology, a scientific endeavor called nanobiology, has become the engine running biotech's analytical tools enterprise. DNA microarrays are an example of these analytical tools. 
In a DNA microarray assay, also known as DNA chips, complementary sequences of nucleotides tagged with either laser-dyes or electron donors are fixed on high-tech substrate a few nanometers apart and hybridize to a sample, generating an optical or electronic signal that represents the amount of genetic material present in the solution. Application on DNA microarrays include but is not limit to DNA sequencing, gene expression studies, genetic disease diagnostics and drug high-throughput screening.
Many of these applications are being targeted for regulatory affairs. Biotech and pharmaceuticals companies are using genetic data to backup the effectiveness of new drugs and therapies. DNA microarrays assays is one format being used but this technology lacks standardization.
The Food and Drug Administration (FDA) worked with academic institutions and biotech companies to tackle this problem. The product of that collaboration was the Microarray Quality Consortium (MAQC) and their findings were recently published in Nature. Their conclusions suggested that most of the problems between microarray platforms comes from the analysis and handling of experimental data, e.g. data normalization and data analysis.
Their report also suggested as a possible source of error the quality of the starting material used to prepare the microarrays. The goal of the consortium was to find best practices for microarray data in regulatory review process.
MAQC is not alone in their crusade, the External RNA Controls Consortium (ERCC) looks to establish standards for gene "spike-in" experiments as well.
In a DNA microarray assay, also known as DNA chips, complementary sequences of nucleotides tagged with either laser-dyes or electron donors are fixed on high-tech substrate a few nanometers apart and hybridize to a sample, generating an optical or electronic signal that represents the amount of genetic material present in the solution. Application on DNA microarrays include but is not limit to DNA sequencing, gene expression studies, genetic disease diagnostics and drug high-throughput screening.
Many of these applications are being targeted for regulatory affairs. Biotech and pharmaceuticals companies are using genetic data to backup the effectiveness of new drugs and therapies. DNA microarrays assays is one format being used but this technology lacks standardization.
The Food and Drug Administration (FDA) worked with academic institutions and biotech companies to tackle this problem. The product of that collaboration was the Microarray Quality Consortium (MAQC) and their findings were recently published in Nature. Their conclusions suggested that most of the problems between microarray platforms comes from the analysis and handling of experimental data, e.g. data normalization and data analysis.
Their report also suggested as a possible source of error the quality of the starting material used to prepare the microarrays. The goal of the consortium was to find best practices for microarray data in regulatory review process.
MAQC is not alone in their crusade, the External RNA Controls Consortium (ERCC) looks to establish standards for gene "spike-in" experiments as well.